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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E; FLAT PE LINER
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MEDACTA INTERNATIONAL SA LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E; FLAT PE LINER Back to Search Results
Catalog Number 01.26.3644HCT
Health Effect - Clinical Code Unspecified Infection (1930)
Date of Event 09/04/2018
Type of Reportable Event Serious Injury
Additional Manufacturer Narrative
Batch review performed on 13 september 2018.Lot 179190: (b)(4) items manufactured and released on 21 march 2018.Expiration date: 2023-03-07.No anomalies found related to the problem.To date, (b)(4) items of the same lot have been already sold without any similar reported event.
 
Event or Problem Description
The patient underwent a washout and liner change due to infection 3 weeks after primary.Pathogen involved: corynebacterium, enterococcus faecal, staphylococcus epidermis.
 
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Brand Name
LINER: CC E CC LIGHT FLAT PE HC LINER Ø 36 / E
Common Device Name
FLAT PE LINER
Manufacturer (Section D)
MEDACTA INTERNATIONAL SA
strada regina
castel san pietro, switzerland 6874
SZ  6874
MDR Report Key7929609
Report Number3005180920-2018-00742
Device Sequence Number2305593
Product Code LZO
UDI-Device Identifier07630030807671
UDI-Public07630030807671
Combination Product (Y/N)N
Initial Reporter CountryAS
PMA/510(K) Number
K120531
Number of Events Summarized1
Summary Report (Y/N)N
Device Implanted Year2018
Device Explanted Year2018
Reporter Type Manufacturer
Report Source company representative
Initial Reporter Occupation Non-Healthcare Professional
Type of Report Initial
Report Date (Section B) 10/03/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Operator of Device Health Professional
Device Expiration Date03/07/2023
Device Catalogue Number01.26.3644HCT
Device Lot Number179190
Was Device Available for Evaluation? No
Type of Report(Section G)Thirty-Day
Initial Date Received by Manufacturer 04/09/2018
Initial Report FDA Received Date10/03/2018
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
Outcome Attributed to Adverse Event Required Intervention;
Patient Age85 YR
Patient Weight89
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